Heidi Splete

ATLANTA – Physicians now have formal approval to vaccinate HIV-exposed or HIV-infected infants and children against rotavirus.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted at its summer meeting to approve changes in wording to the childhood immunization schedule and endorse the use of rotavirus vaccine for HIV-infected infants and children aged 0-18 years.

Dr. Jane Seward, a member of the CDC's division of viral diseases, presented the rationale for the changes, which were approved by the committee.

“Rotavirus is a ubiquitous infection in childhood,” she said. “If these children are not vaccinated, they will almost certainly come down with wild rotavirus disease.”

Although many physicians already routinely administer the rotavirus vaccine to HIV-infected infants and children, Dr. Seward said ACIP proposed modifying the language related to rotavirus vaccination of HIV-infected children based on three main considerations:

▸ The HIV diagnosis may not be established before the age of the first rotavirus vaccine dose.

▸ Natural rotavirus infection does not appear to be more severe in HIV-infected infants.

▸ The rotavirus vaccine (RotaTeq) that would be used in HIV-positive children is attenuated considerably.

The previous wording of the childhood vaccination schedule stated that data were insufficient to support the administration of rotavirus vaccine for HIV-infected children and infants, and therefore practitioners should consider the risks and benefits before vaccinating these patients.

“So the option was there for physicians to vaccinate based on the risks and benefits,” Dr. Seward said.

Although studies in the United States are limited because of the small numbers of HIV-infected children, recent data from large studies in Africa support evidence that rotavirus disease is not more severe in HIV-positive infants and children than in those who don't have HIV, although more data are needed in older children, Dr. Seward explained.

The rotavirus vaccine is as safe as other similar vaccines given to HIV-infected children, she added. She cited the oral polio vaccine as an example; it is considered safe for HIV-infected children and replicates more quickly in the digestive tract than does the rotavirus vaccine.

No trials to assess the safety and efficacy of the rotavirus vaccine in HIV-infected children are planned for the United States, but manufacturers including GlaxoSmithKline and Merck & Co. are planning additional studies in developing countries where the burden of disease is greater, Dr. Seward said.

ATLANTA – Physicians now have formal approval to vaccinate HIV-exposed or HIV-infected infants and children against rotavirus.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted at its summer meeting to approve changes in wording to the childhood immunization schedule and endorse the use of rotavirus vaccine for HIV-infected infants and children aged 0-18 years.

Dr. Jane Seward, a member of the CDC's division of viral diseases, presented the rationale for the changes, which were approved by the committee.

“Rotavirus is a ubiquitous infection in childhood,” she said. “If these children are not vaccinated, they will almost certainly come down with wild rotavirus disease.”

Although many physicians already routinely administer the rotavirus vaccine to HIV-infected infants and children, Dr. Seward said ACIP proposed modifying the language related to rotavirus vaccination of HIV-infected children based on three main considerations:

▸ The HIV diagnosis may not be established before the age of the first rotavirus vaccine dose.

▸ Natural rotavirus infection does not appear to be more severe in HIV-infected infants.

▸ The rotavirus vaccine (RotaTeq) that would be used in HIV-positive children is attenuated considerably.

The previous wording of the childhood vaccination schedule stated that data were insufficient to support the administration of rotavirus vaccine for HIV-infected children and infants, and therefore practitioners should consider the risks and benefits before vaccinating these patients.

“So the option was there for physicians to vaccinate based on the risks and benefits,” Dr. Seward said.

Although studies in the United States are limited because of the small numbers of HIV-infected children, recent data from large studies in Africa support evidence that rotavirus disease is not more severe in HIV-positive infants and children than in those who don't have HIV, although more data are needed in older children, Dr. Seward explained.

The rotavirus vaccine is as safe as other similar vaccines given to HIV-infected children, she added. She cited the oral polio vaccine as an example; it is considered safe for HIV-infected children and replicates more quickly in the digestive tract than does the rotavirus vaccine.

No trials to assess the safety and efficacy of the rotavirus vaccine in HIV-infected children are planned for the United States, but manufacturers including GlaxoSmithKline and Merck & Co. are planning additional studies in developing countries where the burden of disease is greater, Dr. Seward said.

ATLANTA – Physicians now have formal approval to vaccinate HIV-exposed or HIV-infected infants and children against rotavirus.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted at its summer meeting to approve changes in wording to the childhood immunization schedule and endorse the use of rotavirus vaccine for HIV-infected infants and children aged 0-18 years.

Dr. Jane Seward, a member of the CDC's division of viral diseases, presented the rationale for the changes, which were approved by the committee.

“Rotavirus is a ubiquitous infection in childhood,” she said. “If these children are not vaccinated, they will almost certainly come down with wild rotavirus disease.”

Although many physicians already routinely administer the rotavirus vaccine to HIV-infected infants and children, Dr. Seward said ACIP proposed modifying the language related to rotavirus vaccination of HIV-infected children based on three main considerations:

▸ The HIV diagnosis may not be established before the age of the first rotavirus vaccine dose.

▸ Natural rotavirus infection does not appear to be more severe in HIV-infected infants.

▸ The rotavirus vaccine (RotaTeq) that would be used in HIV-positive children is attenuated considerably.

The previous wording of the childhood vaccination schedule stated that data were insufficient to support the administration of rotavirus vaccine for HIV-infected children and infants, and therefore practitioners should consider the risks and benefits before vaccinating these patients.

“So the option was there for physicians to vaccinate based on the risks and benefits,” Dr. Seward said.

Although studies in the United States are limited because of the small numbers of HIV-infected children, recent data from large studies in Africa support evidence that rotavirus disease is not more severe in HIV-positive infants and children than in those who don't have HIV, although more data are needed in older children, Dr. Seward explained.

The rotavirus vaccine is as safe as other similar vaccines given to HIV-infected children, she added. She cited the oral polio vaccine as an example; it is considered safe for HIV-infected children and replicates more quickly in the digestive tract than does the rotavirus vaccine.

No trials to assess the safety and efficacy of the rotavirus vaccine in HIV-infected children are planned for the United States, but manufacturers including GlaxoSmithKline and Merck & Co. are planning additional studies in developing countries where the burden of disease is greater, Dr. Seward said.

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass.

“For example, we estimate that about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector,” said Dr. Lee, who presented results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee.

“In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is approximately $1,200,” she said.

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector to receive vaccines purchased by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in recommended vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults.

“Historically, vaccines weren't so expensive, but now it is getting harder to vaccinate all children with everything due to a lack of increase in 317 funding,” Dr. Lee commented.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers.

The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children, Dr. Lee said.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in approximately 40% of the states. Of note, the ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The survey respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers reported negotiating state contracts with vaccine manufacturers, 9 reported decreasing their purchases of adult vaccines, and 4 reported designating annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said in an interview that she was unable to disclose which states had expanded the FQHCs because the interviewees' names were kept confidential.

In particular, the strategy of expanding FQHC designations to improve access for VFC patients could help relieve the increased stress of paying for vaccines for children, Dr. Lee said.

But the study did not address the other side of vaccine financing–reimbursement–which remains a hot-button issue for physicians.

“All is not well in the realm of private providers,” Dr. Jonathan Temte said during the discussion period following the presentation. “A bigger issue is reimbursement. Even if a vaccine is covered you won't necessarily get paid for all your expenses,” said Dr. Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP. Some physicians are no longer willing to incur the costs of vaccination and are sending children to public clinics, he observed.

For the most current information about coverage, billing, and policies, visit the FQHC Web site at www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass.

“For example, we estimate that about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector,” said Dr. Lee, who presented results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee.

“In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is approximately $1,200,” she said.

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector to receive vaccines purchased by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in recommended vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults.

“Historically, vaccines weren't so expensive, but now it is getting harder to vaccinate all children with everything due to a lack of increase in 317 funding,” Dr. Lee commented.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers.

The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children, Dr. Lee said.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in approximately 40% of the states. Of note, the ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The survey respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers reported negotiating state contracts with vaccine manufacturers, 9 reported decreasing their purchases of adult vaccines, and 4 reported designating annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said in an interview that she was unable to disclose which states had expanded the FQHCs because the interviewees' names were kept confidential.

In particular, the strategy of expanding FQHC designations to improve access for VFC patients could help relieve the increased stress of paying for vaccines for children, Dr. Lee said.

But the study did not address the other side of vaccine financing–reimbursement–which remains a hot-button issue for physicians.

“All is not well in the realm of private providers,” Dr. Jonathan Temte said during the discussion period following the presentation. “A bigger issue is reimbursement. Even if a vaccine is covered you won't necessarily get paid for all your expenses,” said Dr. Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP. Some physicians are no longer willing to incur the costs of vaccination and are sending children to public clinics, he observed.

For the most current information about coverage, billing, and policies, visit the FQHC Web site at www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass.

“For example, we estimate that about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector,” said Dr. Lee, who presented results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee.

“In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is approximately $1,200,” she said.

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector to receive vaccines purchased by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in recommended vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults.

“Historically, vaccines weren't so expensive, but now it is getting harder to vaccinate all children with everything due to a lack of increase in 317 funding,” Dr. Lee commented.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers.

The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children, Dr. Lee said.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in approximately 40% of the states. Of note, the ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The survey respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers reported negotiating state contracts with vaccine manufacturers, 9 reported decreasing their purchases of adult vaccines, and 4 reported designating annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said in an interview that she was unable to disclose which states had expanded the FQHCs because the interviewees' names were kept confidential.

In particular, the strategy of expanding FQHC designations to improve access for VFC patients could help relieve the increased stress of paying for vaccines for children, Dr. Lee said.

But the study did not address the other side of vaccine financing–reimbursement–which remains a hot-button issue for physicians.

“All is not well in the realm of private providers,” Dr. Jonathan Temte said during the discussion period following the presentation. “A bigger issue is reimbursement. Even if a vaccine is covered you won't necessarily get paid for all your expenses,” said Dr. Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP. Some physicians are no longer willing to incur the costs of vaccination and are sending children to public clinics, he observed.

For the most current information about coverage, billing, and policies, visit the FQHC Web site at www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – Concerns about removing financial barriers to childhood vaccination took center stage at an immunization congress sponsored by the American Academy of Pediatrics and the American Medical Association, Dr. Walter Orenstein reported at the summer meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

One focus of the congress was on recommendations that could be implemented within existing legislation, said Dr. Orenstein, who currently heads a program for vaccine policy and development at Emory University in Atlanta and is a former director of the CDC's National Vaccine Program.

At the meeting, he presented a summary of the recommendations adopted at the congress for improving financing for pediatric immunization. The recommendations remain under consideration by the National Vaccine Advisory Committee; no official document has been produced.

Barriers to adequate vaccine financing include underinsurance, lack of reimbursement, and concerns about vaccine cost, storage, and handling.

But resolving the financial barriers is not enough to ensure high childhood vaccination coverage, and private and public collaboration in vaccine delivery should be maintained, Dr. Orenstein emphasized.

“The best way to ensure continued private sector participation is to [ensure] not only reimbursement for what they do but some reasonable return on the investment beyond cost,” he said.

The congress attendees included approximately 150 representatives from medical and health societies, private providers, insurers, employers, vaccine manufacturers, the federal government, and state and local governments. They agreed that vaccines are different from other disease prevention measures because vaccines protect other members of society in addition to the vaccinees. Consequently, every state must address the financing problem to prevent the development of large clusters of unvaccinated persons, who could spread disease.

Dr. Orenstein presented recommendations from the congress that could guide the medical community's efforts to improve pediatric vaccine financing:

▸ Work with Federally Qualified Health Centers to delegate authority to public health clinics to vaccinate underinsured children through the Vaccines for Children program. This strategy would reduce some pressure on the limited Section 317 funding.

▸ Obtain data on the actual costs of delivering vaccines in private practice settings, so all medical societies could use this data to advocate with insurers for adequate reimbursement.

▸ Work with manufacturers to get better deals for vaccines, especially for new vaccines that cost more up front.

▸ Combine the resources of the American Academy of Pediatrics, American Academy of Family Physicians, and American Medical Association to define the CPT codes for adequate vaccination reimbursement.

▸ Create tax credits for insurers and providers to eliminate underinsurance. The congress attendees agreed that more work was needed to evaluate whether tax incentives would be feasible and help to immunize more children.

▸ Convene a working group to determine whether a federal purchase of vaccines or universal federal funding is worth pursuing.

▸ Acquire the data from the Centers for Medicare and Medicaid Services that were used to develop the current flu vaccine administration fees. If these rates are published and distributed, physicians can use them to advocate for higher fees for other vaccines.

▸ Collect data on the true cost of acquiring and administering combination vaccines. The Advisory Committee on Immunization Practices supports the use of combination vaccines rather than single vaccines whenever possible, but data are needed to show that combination vaccines cost more to administer than do single vaccines and should be reimbursed accordingly.

▸ Obtain data on the best business practices that minimize costs related to vaccines and vaccination, and distribute this information to health care providers.

ATLANTA – Concerns about removing financial barriers to childhood vaccination took center stage at an immunization congress sponsored by the American Academy of Pediatrics and the American Medical Association, Dr. Walter Orenstein reported at the summer meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

One focus of the congress was on recommendations that could be implemented within existing legislation, said Dr. Orenstein, who currently heads a program for vaccine policy and development at Emory University in Atlanta and is a former director of the CDC's National Vaccine Program.

At the meeting, he presented a summary of the recommendations adopted at the congress for improving financing for pediatric immunization. The recommendations remain under consideration by the National Vaccine Advisory Committee; no official document has been produced.

Barriers to adequate vaccine financing include underinsurance, lack of reimbursement, and concerns about vaccine cost, storage, and handling.

But resolving the financial barriers is not enough to ensure high childhood vaccination coverage, and private and public collaboration in vaccine delivery should be maintained, Dr. Orenstein emphasized.

“The best way to ensure continued private sector participation is to [ensure] not only reimbursement for what they do but some reasonable return on the investment beyond cost,” he said.

The congress attendees included approximately 150 representatives from medical and health societies, private providers, insurers, employers, vaccine manufacturers, the federal government, and state and local governments. They agreed that vaccines are different from other disease prevention measures because vaccines protect other members of society in addition to the vaccinees. Consequently, every state must address the financing problem to prevent the development of large clusters of unvaccinated persons, who could spread disease.

Dr. Orenstein presented recommendations from the congress that could guide the medical community's efforts to improve pediatric vaccine financing:

▸ Work with Federally Qualified Health Centers to delegate authority to public health clinics to vaccinate underinsured children through the Vaccines for Children program. This strategy would reduce some pressure on the limited Section 317 funding.

▸ Obtain data on the actual costs of delivering vaccines in private practice settings, so all medical societies could use this data to advocate with insurers for adequate reimbursement.

▸ Work with manufacturers to get better deals for vaccines, especially for new vaccines that cost more up front.

▸ Combine the resources of the American Academy of Pediatrics, American Academy of Family Physicians, and American Medical Association to define the CPT codes for adequate vaccination reimbursement.

▸ Create tax credits for insurers and providers to eliminate underinsurance. The congress attendees agreed that more work was needed to evaluate whether tax incentives would be feasible and help to immunize more children.

▸ Convene a working group to determine whether a federal purchase of vaccines or universal federal funding is worth pursuing.

▸ Acquire the data from the Centers for Medicare and Medicaid Services that were used to develop the current flu vaccine administration fees. If these rates are published and distributed, physicians can use them to advocate for higher fees for other vaccines.

▸ Collect data on the true cost of acquiring and administering combination vaccines. The Advisory Committee on Immunization Practices supports the use of combination vaccines rather than single vaccines whenever possible, but data are needed to show that combination vaccines cost more to administer than do single vaccines and should be reimbursed accordingly.

▸ Obtain data on the best business practices that minimize costs related to vaccines and vaccination, and distribute this information to health care providers.

ATLANTA – Concerns about removing financial barriers to childhood vaccination took center stage at an immunization congress sponsored by the American Academy of Pediatrics and the American Medical Association, Dr. Walter Orenstein reported at the summer meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

One focus of the congress was on recommendations that could be implemented within existing legislation, said Dr. Orenstein, who currently heads a program for vaccine policy and development at Emory University in Atlanta and is a former director of the CDC's National Vaccine Program.

At the meeting, he presented a summary of the recommendations adopted at the congress for improving financing for pediatric immunization. The recommendations remain under consideration by the National Vaccine Advisory Committee; no official document has been produced.

Barriers to adequate vaccine financing include underinsurance, lack of reimbursement, and concerns about vaccine cost, storage, and handling.

But resolving the financial barriers is not enough to ensure high childhood vaccination coverage, and private and public collaboration in vaccine delivery should be maintained, Dr. Orenstein emphasized.

“The best way to ensure continued private sector participation is to [ensure] not only reimbursement for what they do but some reasonable return on the investment beyond cost,” he said.

The congress attendees included approximately 150 representatives from medical and health societies, private providers, insurers, employers, vaccine manufacturers, the federal government, and state and local governments. They agreed that vaccines are different from other disease prevention measures because vaccines protect other members of society in addition to the vaccinees. Consequently, every state must address the financing problem to prevent the development of large clusters of unvaccinated persons, who could spread disease.

Dr. Orenstein presented recommendations from the congress that could guide the medical community's efforts to improve pediatric vaccine financing:

▸ Work with Federally Qualified Health Centers to delegate authority to public health clinics to vaccinate underinsured children through the Vaccines for Children program. This strategy would reduce some pressure on the limited Section 317 funding.

▸ Obtain data on the actual costs of delivering vaccines in private practice settings, so all medical societies could use this data to advocate with insurers for adequate reimbursement.

▸ Work with manufacturers to get better deals for vaccines, especially for new vaccines that cost more up front.

▸ Combine the resources of the American Academy of Pediatrics, American Academy of Family Physicians, and American Medical Association to define the CPT codes for adequate vaccination reimbursement.

▸ Create tax credits for insurers and providers to eliminate underinsurance. The congress attendees agreed that more work was needed to evaluate whether tax incentives would be feasible and help to immunize more children.

▸ Convene a working group to determine whether a federal purchase of vaccines or universal federal funding is worth pursuing.

▸ Acquire the data from the Centers for Medicare and Medicaid Services that were used to develop the current flu vaccine administration fees. If these rates are published and distributed, physicians can use them to advocate for higher fees for other vaccines.

▸ Collect data on the true cost of acquiring and administering combination vaccines. The Advisory Committee on Immunization Practices supports the use of combination vaccines rather than single vaccines whenever possible, but data are needed to show that combination vaccines cost more to administer than do single vaccines and should be reimbursed accordingly.

▸ Obtain data on the best business practices that minimize costs related to vaccines and vaccination, and distribute this information to health care providers.

The Centers for Disease Control and Prevention's updated recommendations for the 2007-2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) has published its updated flu vaccination recommendations for the 2007-2008 flu season in the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1-40). The updates include:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and encourage all health care providers to get flu shots.

▸ For physicians. In addition to those who were not previously vaccinated, children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Physicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6-10 weeks after the first.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is approved only for healthy, nonpregnant individuals aged 5-49 years. The influenza vaccine for the 2007-2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, and two strains used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages physicians to be proactive about vaccinating their patients. The updated recommendations will be posted at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007-2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) has published its updated flu vaccination recommendations for the 2007-2008 flu season in the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1-40). The updates include:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and encourage all health care providers to get flu shots.

▸ For physicians. In addition to those who were not previously vaccinated, children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Physicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6-10 weeks after the first.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is approved only for healthy, nonpregnant individuals aged 5-49 years. The influenza vaccine for the 2007-2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, and two strains used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages physicians to be proactive about vaccinating their patients. The updated recommendations will be posted at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007-2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) has published its updated flu vaccination recommendations for the 2007-2008 flu season in the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1-40). The updates include:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and encourage all health care providers to get flu shots.

▸ For physicians. In addition to those who were not previously vaccinated, children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Physicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6-10 weeks after the first.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is approved only for healthy, nonpregnant individuals aged 5-49 years. The influenza vaccine for the 2007-2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, and two strains used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages physicians to be proactive about vaccinating their patients. The updated recommendations will be posted at www.cdc.gov/flu

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass. “We estimate about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector.”

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee, who presented results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is about $1,200.”

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector for vaccines bought by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in suggested vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers. The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in about 40% of the states. The ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers negotiated state contracts with vaccine manufacturers, 9 decreased their purchases of adult vaccines, and 4 designated annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said she was unable to disclose which states had expanded the FQHCs because interviewees' names were kept confidential.

But the study did not address reimbursement, which remains a hot-button issue for physicians. “A bigger issue is reimbursement. Even if a vaccine is covered, you won't necessarily get paid for all your expenses,” said Dr. Jonathan Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP, in a discussion. For more information, visit www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass. “We estimate about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector.”

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee, who presented results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is about $1,200.”

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector for vaccines bought by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in suggested vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers. The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in about 40% of the states. The ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers negotiated state contracts with vaccine manufacturers, 9 decreased their purchases of adult vaccines, and 4 designated annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said she was unable to disclose which states had expanded the FQHCs because interviewees' names were kept confidential.

But the study did not address reimbursement, which remains a hot-button issue for physicians. “A bigger issue is reimbursement. Even if a vaccine is covered, you won't necessarily get paid for all your expenses,” said Dr. Jonathan Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP, in a discussion. For more information, visit www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass. “We estimate about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector.”

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee, who presented results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is about $1,200.”

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector for vaccines bought by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in suggested vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers. The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in about 40% of the states. The ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers negotiated state contracts with vaccine manufacturers, 9 decreased their purchases of adult vaccines, and 4 designated annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said she was unable to disclose which states had expanded the FQHCs because interviewees' names were kept confidential.

But the study did not address reimbursement, which remains a hot-button issue for physicians. “A bigger issue is reimbursement. Even if a vaccine is covered, you won't necessarily get paid for all your expenses,” said Dr. Jonathan Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP, in a discussion. For more information, visit www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The safety profile for herpes zoster vaccine Zostavax, manufactured by Merck & Co. was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

“Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials,” said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1, 2007, to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths. Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction–the most commonly reported adverse event–was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available, but the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine.

The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions that exist in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” he said.

Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA – The safety profile for herpes zoster vaccine Zostavax, manufactured by Merck & Co. was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

“Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials,” said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1, 2007, to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths. Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction–the most commonly reported adverse event–was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available, but the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine.

The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions that exist in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” he said.

Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA – The safety profile for herpes zoster vaccine Zostavax, manufactured by Merck & Co. was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

“Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials,” said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1, 2007, to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths. Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction–the most commonly reported adverse event–was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available, but the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine.

The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions that exist in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” he said.

Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

WASHINGTON – Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

“The program facilitated our efforts in providing smoking cessation counseling and offering NRT to all these identified patients,” the researchers said. Also, adding smoking status to the EMR helped physicians retrieve information more easily, which may help with long-term studies of patients' smoking status after they leave the hospital.

WASHINGTON – Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

“The program facilitated our efforts in providing smoking cessation counseling and offering NRT to all these identified patients,” the researchers said. Also, adding smoking status to the EMR helped physicians retrieve information more easily, which may help with long-term studies of patients' smoking status after they leave the hospital.

WASHINGTON – Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

“The program facilitated our efforts in providing smoking cessation counseling and offering NRT to all these identified patients,” the researchers said. Also, adding smoking status to the EMR helped physicians retrieve information more easily, which may help with long-term studies of patients' smoking status after they leave the hospital.

The Centers for Disease Control and Prevention's updated recommendations for the 2007–2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007–2008 flu season in the July 13 issue of the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1–40).

New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6–10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is currently approved only for healthy, nonpregnant individuals aged 5–49 years. The influenza vaccine for the 2007–2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for influenza complications.

▸ Individuals in nursing homes or chronic care facilities.

Updates to the 2007–2008 flu vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007–2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007–2008 flu season in the July 13 issue of the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1–40).

New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6–10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is currently approved only for healthy, nonpregnant individuals aged 5–49 years. The influenza vaccine for the 2007–2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for influenza complications.

▸ Individuals in nursing homes or chronic care facilities.

Updates to the 2007–2008 flu vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007–2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007–2008 flu season in the July 13 issue of the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1–40).

New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6–10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is currently approved only for healthy, nonpregnant individuals aged 5–49 years. The influenza vaccine for the 2007–2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for influenza complications.

▸ Individuals in nursing homes or chronic care facilities.

Updates to the 2007–2008 flu vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

ATLANTA — The safety profile for herpes zoster vaccine Zostavax, manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

“Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials,” said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1, 2007, to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths. Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said.

More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70–79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available, but the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” Dr. Chaves said. Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA — The safety profile for herpes zoster vaccine Zostavax, manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

“Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials,” said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1, 2007, to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths. Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said.

More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70–79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available, but the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” Dr. Chaves said. Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA — The safety profile for herpes zoster vaccine Zostavax, manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

“Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials,” said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1, 2007, to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths. Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said.

More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70–79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available, but the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” Dr. Chaves said. Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

WASHINGTON — Clinicians ignored more than half of drug allergy warnings generated by computerized physician order entry programs, based on a review of nearly 30,000 medication orders for 2,732 hospitalized patients.

To determine how often computerized allergy warnings for medications were overridden and why, Philip J. Schneider of the Ohio State University, Columbus, and his colleagues analyzed data from four 1-week intervals and one 16-week interval between August 2003 and February 2005. They presented their findings in a poster at a conference sponsored by the National Patient Safety Foundation.

Computerized physician order entry (CPOE) programs allow physicians and other qualified clinicians to enter medication orders directly into a database in order to reduce the ambiguity of handwritten prescriptions. Once a prescription has been entered into the database, the system generates alerts regarding patient allergies and potential drug-drug interactions.

Clinicians overrode warnings about potential drug allergies in 56% of the orders, and changed the medication in 44% of the orders.

When the data were broken down by provider type, physicians were the least likely to override warnings, although more than half of them did so. A total of 54% of physician medication decisions overrode the warnings, compared with decisions by pharmacists (55%) and nurses (61%).

The most commonly cited reason for overriding the warnings was that the patient had tolerated the drug in the past. Other reasons included “not a true allergy,” “medical reason outweighed risk,” and “physician/pharmacist approved.”

CPOEs are not yet widely used, but they have the potential to improve patient safety, the researchers noted.

WASHINGTON — Clinicians ignored more than half of drug allergy warnings generated by computerized physician order entry programs, based on a review of nearly 30,000 medication orders for 2,732 hospitalized patients.

To determine how often computerized allergy warnings for medications were overridden and why, Philip J. Schneider of the Ohio State University, Columbus, and his colleagues analyzed data from four 1-week intervals and one 16-week interval between August 2003 and February 2005. They presented their findings in a poster at a conference sponsored by the National Patient Safety Foundation.

Computerized physician order entry (CPOE) programs allow physicians and other qualified clinicians to enter medication orders directly into a database in order to reduce the ambiguity of handwritten prescriptions. Once a prescription has been entered into the database, the system generates alerts regarding patient allergies and potential drug-drug interactions.

Clinicians overrode warnings about potential drug allergies in 56% of the orders, and changed the medication in 44% of the orders.

When the data were broken down by provider type, physicians were the least likely to override warnings, although more than half of them did so. A total of 54% of physician medication decisions overrode the warnings, compared with decisions by pharmacists (55%) and nurses (61%).

The most commonly cited reason for overriding the warnings was that the patient had tolerated the drug in the past. Other reasons included “not a true allergy,” “medical reason outweighed risk,” and “physician/pharmacist approved.”

CPOEs are not yet widely used, but they have the potential to improve patient safety, the researchers noted.

WASHINGTON — Clinicians ignored more than half of drug allergy warnings generated by computerized physician order entry programs, based on a review of nearly 30,000 medication orders for 2,732 hospitalized patients.

To determine how often computerized allergy warnings for medications were overridden and why, Philip J. Schneider of the Ohio State University, Columbus, and his colleagues analyzed data from four 1-week intervals and one 16-week interval between August 2003 and February 2005. They presented their findings in a poster at a conference sponsored by the National Patient Safety Foundation.

Computerized physician order entry (CPOE) programs allow physicians and other qualified clinicians to enter medication orders directly into a database in order to reduce the ambiguity of handwritten prescriptions. Once a prescription has been entered into the database, the system generates alerts regarding patient allergies and potential drug-drug interactions.

Clinicians overrode warnings about potential drug allergies in 56% of the orders, and changed the medication in 44% of the orders.

When the data were broken down by provider type, physicians were the least likely to override warnings, although more than half of them did so. A total of 54% of physician medication decisions overrode the warnings, compared with decisions by pharmacists (55%) and nurses (61%).

The most commonly cited reason for overriding the warnings was that the patient had tolerated the drug in the past. Other reasons included “not a true allergy,” “medical reason outweighed risk,” and “physician/pharmacist approved.”

CPOEs are not yet widely used, but they have the potential to improve patient safety, the researchers noted.